| CTRI Number |
CTRI/2025/06/089016 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Use of Shiv mix as analgesia for spine surgeries. |
|
Scientific Title of Study
|
“A clinical comparative study to evaluate and compare the efficacy and safety of simple combination of analgesics i.e. Shiv mix with opioid for perioperative analgesia, hemodynamic and recovery profile in spine surgeries posted under general anesthesia.”
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogita Sorte |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences And Research Centre Bhopal |
| Address |
A 16 BMHRC campus raisen bypass road Karond Bhopal
same as above
Bhopal
MADHYA PRADESH
462038
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogita Sorte |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences And Research Centre Bhopal |
| Address |
A 16 BMHRC campus raisen bypass road Karond Bhopal
same as above
Bhopal
MADHYA PRADESH
462038
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Sorte |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences And Research Centre Bhopal |
| Address |
A 16 BMHRC campus raisen bypass road Karond Bhopal
same as above
Bhopal
MADHYA PRADESH
462038
India |
| Phone |
9806179234 |
| Fax |
|
| Email |
yogitanimje84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Peoples College of Medical Sciences And Research Centre Bhopal |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogita Sorte |
Peoples College of Medical Sciences And Research Centre |
Department of Anaesthesiology Peoples College of Medical Sciences And Research Centre Bhanpur Raisen Bypass road Bhopal India 462037
Bhopal
MADHYA PRADESH |
9806179234
yogitanimje84@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples College of Medical Sciences And Research Centre, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In our present study, we use intravenous Shiv mix in one group and fentanyl in other group. |
To compare preoperative haemodynamic parameters in both groups.
To compare laryngoscopy and intubation response in both groups.
To compare cardiorespiratory parameters during induction and at regular intervals in both groups.
To compare emergence time in both groups.
To compare duration of Surgery in both groups.
To compare recovery profile at the end of Surgery by assessing Eye opening/ Purposeful movements (hand grip)/ Cough and gag reflex in both groups.
To compare post Operative Nausea and Vomiting (PONV) in both groups.Methodology-
200 adult patients of either sex of physical status ASA grade 1 and 2 undergoing elective surgery under general anaesthesia will be allocated into Group A and Group B of 100 patients using envelop method.
Group A: received Inj. Fentanyl prior to laryngoscopy and intubation.
Group B: received Inj. Lignocaine + Inj Paracetamol + Inj. Magnesium sulphate over a period of 20 minutes prior to laryngoscopy and intubation as premedication for perioperative analgesia.
|
| Intervention |
In our study, we use intravenous Shiv mix in one group and fentanyl in other group for comparison. |
Patients will be assigned to one of the following two groups:
Group A: received Inj. Fentanyl prior to laryngoscopy and intubation.
Group B: received Inj. Lignocaine 3 ml + Inj Paracetamol I gm + Inj. Magnesium sulphate 1 gram over a period of 20 minutes prior to laryngoscopy and intubation as premedication for perioperative analgesia.
All patients will be explained about the sequence of anaesthetic procedure and a good IV access will be secured in the operation theater and all monitoring devices attached which included devices measuring heart rate, ECG, SpO2, non invasive blood pressure and respiratory rate. Baseline hemodynamic parameters, respiratory rate, ECG and SpO2 will be recorded.
All patients will be given injection i.v. Ondansetron 4 mg, inj. i.v Ranitidine 50 mg, inj. i.v. Glycopyrolate 0.02 mg , inj. i.v. Midazolam 1 mg as premedication.
Group A patients will be given Inj. i.v. Fentanyl 1-2 microgram per kilogram of the body weight and then induction agent i.e. inj. i.v. Propofol 2-3 mg per kilogram of the body weight and muscle relaxant i.e. inj. i.v. Vecuronium. After 4 minutes the laryngoscopy will be performed and the patient will be intubated, during the procedure the vitals will be recorded i.e. Pulse rate, Blood pressure (SBP, DBP and MBP), SpO2 and recorded repeatedly after every one minute till the confirmation of the endotracheal tube in the trachea and fixation. After that vitals will be recorded after every 3 mintues till the painting and draping of the desired surgical area. Inj. i.v. Diclofenac 75 mg will be given as a maintence analgesia. After that vitals will be recorded after every 5 minutes till the end of the Surgery.
|
| Intervention |
In our study, we use intravenous Shiv mix in one group and fentanyl in other group for comparison. |
Patients will be assigned to one of the following two groups: Group A: received Inj. Fentanyl prior to laryngoscopy and intubation. Group B: received Inj. Lignocaine 3 ml + Inj Paracetamol I gm + Inj. Magnesium sulphate 1 gram over a period of 20 minutes prior to laryngoscopy and intubation as premedication for perioperative analgesia. All patients will be explained about the sequence of anaesthetic procedure and a good IV access will be secured in the operation theater and all monitoring devices attached which included devices measuring heart rate, ECG, SpO2, non invasive blood pressure and respiratory rate. Baseline hemodynamic parameters, respiratory rate, ECG and SpO2 will be recorded. All patients will be given injection i.v. Ondansetron 4 mg, inj. i.v Ranitidine 50 mg, inj. i.v. Glycopyrolate 0.02 mg , inj. i.v. Midazolam 1 mg as premedication. Group A patients will be given Inj. i.v. Fentanyl 1-2 microgram per kilogram of the body weight and then induction agent i.e. inj. i.v. Propofol 2-3 mg per kilogram of the body weight and muscle relaxant i.e. inj. i.v. Vecuronium. After 4 minutes the laryngoscopy will be performed and the patient will be intubated, during the procedure the vitals will be recorded i.e. Pulse rate, Blood pressure (SBP, DBP and MBP), SpO2 and recorded repeatedly after every one minute till the confirmation of the endotracheal tube in the trachea and fixation. After that vitals will be recorded after every 3 mintues till the painting and draping of the desired surgical area. Inj. i.v. Diclofenac 75 mg will be given as a maintence analgesia. After that vitals will be recorded after every 5 minutes till the end of the Surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
200 patients of ASA grade I and 2 between the ages of 18 - 60 years, who underwent surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients for whom any component of mixture is contraindicated
Refusal to give consent
History or family history of malignant hyperthermia
ASA physical status –III or higher will be excluded
Patients having history of convulsions, meningitis, infections, anaemia (Hb % <9 gm/dl) or any congenital heart disease
Patients having hepatic, renal or neuromuscular disease
Patients having respiratory system disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| With Shiv mix, we expect less inhalational agent and less muscle relaxant. |
Patients satisfaction after surgery.
Demand for first rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
200 adult patients of either sex of physical status ASA grade 1 and 2 undergoing elective surgery under general anaesthesia will be allocated into Group A and Group B of 100 patients using envelop method. Group A: received Inj. Fentanyl prior to laryngoscopy and intubation. Group B: received Inj. Lignocaine + Inj Paracetamol + Inj. Magnesium sulphate over a period of 20 minutes prior to laryngoscopy and intubation as premedication for perioperative analgesia. Patients will be assigned to one of the following two groups: Group A: received Inj. Fentanyl prior to laryngoscopy and intubation. Group B: received Inj. Lignocaine 3 ml + Inj Paracetamol I gm + Inj. Magnesium sulphate 1 gram over a period of 20 minutes prior to laryngoscopy and intubation as premedication for perioperative analgesia. •All patients will be explained about the sequence of anaesthetic procedure and a good IV access will be secured in the operation theater and all monitoring devices attached which included devices measuring heart rate, ECG, SpO2, non invasive blood pressure and respiratory rate. Baseline hemodynamic parameters, respiratory rate, ECG and SpO2 will be recorded. •All patients will be given injection i.v. Ondansetron 4 mg, inj. i.v Ranitidine 50 mg, inj. i.v. Glycopyrolate 0.02 mg , inj. i.v. Midazolam 1 mg as premedication. •Group A patients will be given Inj. i.v. Fentanyl 1-2 microgram per kilogram of the body weight and then induction agent i.e. inj. i.v. Propofol 2-3 mg per kilogram of the body weight and muscle relaxant i.e. inj. i.v. Vecuronium. After 4 minutes the laryngoscopy will be performed and the patient will be intubated, during the procedure the vitals will be recorded i.e. Pulse rate, Blood pressure (SBP, DBP and MBP), SpO2 and recorded repeatedly after every one minute till the confirmation of the endotracheal tube in the trachea and fixation. After that vitals will be recorded after every 3 mintues till the painting and draping of the desired surgical area. Inj. i.v. Diclofenac 75 mg will be given as a maintence analgesia. After that vitals will be recorded after every 5 minutes till the end of the Surgery. Study started and running succeessfully. |